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Completed

NCT Number: NCT03419468

LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment

The Self Geriatric Assessment Measure [SGAM] is based on a standard diagnostic tool used to evaluate geriatric cancer patients in order to determine the appropriateness of cancer directed therapy at LCI. This questionnaire has sections that matches portions of a self-administered geriatric assessment in patients aged 70 or older with malignancy. The prolonged duration of time needed to complete the assessment makes its performance less feasible in standard practice settings.

In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.

This study proposes the use of an iPad tablet to administer the SGAM may help:

Improve the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting

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Key information

Conditions

Self Geriatric Assessment Measure (SGAM)

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

About this study

Primary Objective

Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.

Secondary Objectives

To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.

To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

To describe the rate of technical issues experienced by iPad survey users.

To assess and compare the completion rates and times to completion of the gold standard written format.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following criteria:

  • At least 70 years of age
  • Histologically or cytologically confirmed malignancy within the past 1 year
  • Ability to read and understand English
  • Willingness to complete either tablet or paper based assessment independently and without assistance from caregiver, if applicable
  • Willingness and ability to understand and sign a written informed consent document

Exclusion criteria

Subjects must not meet any of the following criteria:

  • Any prior history of whole brain radiation therapy for known brain metastasis
  • Known cerebrovascular event within the last 4 weeks from enrollment
  • Known to be legally blind or has a history of severe hearing loss that could impair ability to complete questionnaire in the opinion of the investigator

Treatment and study plan

Self Geriatric Assessment Measure (SGAM)

Other

Self Geriatric Assessment Measure

Primary outcomes

  1. Survey completion rate

    Time frame: 12 months

    Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the SGAM in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.

Secondary outcomes

  1. Rate of survey completion without assistance

    Time frame: 12 months

    To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.

  2. Total time of interaction with iPad survey

    Time frame: 12 months

    To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

  3. Percentage of recorded responses

    Time frame: 12 months

    To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

  4. Rate of technical issues within iPad group

    Time frame: 12 months

    To describe the rate of technical issues experienced by iPad survey users.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

LCI-GER-NOS-TAB-001: Pilot Study of a Tablet to Administer the Cancer-Specific Geriatric Assessment (CSGA) in Geriatric Patients With Cancer

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.